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FDA 510(k)

MEDICON Spinal Spreading Systems

K-Number: K161680 · 2017-03-24

ApplicantMedicon EG
Decision Date2017-03-24
Product CodeGZT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MEDICON Spinal Spreading Systems is the device name listed in this FDA 510(k) record. The listed applicant is Medicon EG. It received FDA 510(k) clearance on 2017-03-24 under 510(k) number K161680. The device is classified under product code GZT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDICON Spinal Spreading Systems?

MEDICON Spinal Spreading Systems is a medical device that received FDA 510(k) clearance on 2017-03-24. The listed applicant is Medicon EG. The 510(k) number is K161680.

When did MEDICON Spinal Spreading Systems receive FDA 510(k) clearance?

MEDICON Spinal Spreading Systems received FDA 510(k) clearance on 2017-03-24, under 510(k) number K161680.

Who is the listed applicant for MEDICON Spinal Spreading Systems?

The FDA 510(k) record lists Medicon EG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDICON Spinal Spreading Systems?

The FDA product code for MEDICON Spinal Spreading Systems is GZT.

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Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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